MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS STREAMLINE 4.0MM X 25MM - CE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number M003111FPP0

Device Problems Fracture (1260); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2020

Event Type  malfunction  

Manufacturer Narrative

Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.Visual inspection revealed the proximal end of the stabilizer was kinked, the proximal of the delivery catheter was deformed.Additionally, the stent was partially deployed, and the distal end of the delivery catheter was broken/damaged with the braid wire exposed and the ro (radiopaque) marker band missing.Following the functional test ,the delivery catheter was flushed, and the stabilizer was advanced to deploy the stent, the distal end of the stabilizer was broken/fractured at 6cm from the distal end.The deployed stent was deformed at both ends and the stabilizer was unable to be removed from the catheter due to the damage noted.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.As per the additional information there was a sharp curve in the carotid.The device was returned and the damage noted to the device is indicative of the reported event.It is probable that the device was damaged during navigation to the target vessel, causing the reported and analysed defects.An assignable cause of procedural factors will be assigned to the reported event and to the analysed , as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.

Event Description

Analysis of the returned device revealed that the subject stent stabilizer broken/fractured during use, and the ro (radiopaque) marker band was missing.There were no clinical consequence to the patient reported as a result of this event.Additional information received on 10/24/2020 indicated that there were no markers in the patient.That there were markers at the beginning of the procedure and it was possible to visualize them until the moment of stent removal.In addition, he stressed that the defect / reason for the subject stent not progressing was a loose wire.The images of the patient's angiography, and also a video were made on a table with the streamline already outside the patient, where it shows on the markers on the stent.

• Brand Name: SURPASS STREAMLINE 4.0MM X 25MM - CE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 10596794
• MDR Text Key: 209455124
• Report Number: 3008881809-2020-00278
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2021
• Device Catalogue Number: M003111FPP0
• Device Lot Number: 20474883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 69